Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
  • Print
  • Share
  • E-mail
-

Search results from the "OB_Rx" table for query on "022580."


Active Ingredient: PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: QSYMIA
Applicant: VIVUS
Strength: EQ 3.75MG BASE;23MG
Application Number: N022580
Product Number: 001
Approval Date: Jul 17, 2012
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View
Active Ingredient: PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: QSYMIA
Applicant: VIVUS
Strength: EQ 7.5MG BASE;46MG
Application Number: N022580
Product Number: 002
Approval Date: Jul 17, 2012
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View
Active Ingredient: PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: QSYMIA
Applicant: VIVUS
Strength: EQ 11.25MG BASE;69MG
Application Number: N022580
Product Number: 003
Approval Date: Jul 17, 2012
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View
Active Ingredient: PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: QSYMIA
Applicant: VIVUS
Strength: EQ 15MG BASE;92MG
Application Number: N022580
Product Number: 004
Approval Date: Jul 17, 2012
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Return to Electronic Orange Book Home Page

FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:
    Orange Book Data - Monthly
    Generic Drug Product Information & Patent Information - Daily
    Orange Book Data Updated Through April, 2013
    Patent and Generic Drug Product Data Last Updated: May 24, 2013
-
-